|The infrared light emitted from the processor's probe travels through the ear canal and strikes the EarLens implant, which then vibrates the eardrum, creating the perception of sound.--Courtesy of EarLens|
Hearing aids aren't particularly useful or affordable for most Americans who need them, but the U.S. Food and Drug Administration is hoping to help change that. It has disclosed new efforts to advance hearing aid technology and patient access to the devices. And a top med tech industry venture firm, NEA, has already made at least a trio of bets in the hearing aid category.
The agency's tactics to do so include holding a public workshop on April 21 to solicit input from stakeholders and the public on "alternative models for regulation that would accelerate innovation while still enabling quality design and manufacturing for hearing aids," the FDA said in a statement.
It will also reopen the comment period on draft guidance regarding the difference in regulatory requirements between hearing aids, which are typically considered Class I by the agency and don't require a PMA review or even regulatory clearance, and personal sound amplification products (PSAPs), which are unregulated by the agency and considered to be wearable electronic products for non-hearing impaired people in difficult environments. The comment period has been extended through May 19.
|CDRH's William Maisel|
"The FDA recognizes that hearing aids are an important and often underutilized medical device for those with hearing impairment," said Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, in a statement. "Additional insight from all stakeholders will help us to better understand how we can overcome the barriers to access and spur the development of devices that compensate for impaired hearing."
Part of the impetus behind these latest FDA moves on hearing aids stems from a recent report from the President's Council of Advisors in Science and Technology (PCAST). It argued that the agency could "enhance the pace of innovation" and lead to a "decrease in cost and improvement in capability, convenience and use of assistive hearing devices."
Only about 30% of older adults, age 70 and above, who need hearing aids actually have ever used them. That's even worse among younger adults, where the rate is only 16%, according to the National Institute on Deafness and Other Communication Disorders (NIDCD). Elderly-focused Medicare does not reimburse for hearing aids.
|Eargo hearing aid--Courtesy of Eargo|
But there are some hopeful signals for hearing aid innovation. The FDA has given the nod to a few new kinds of hearing aids in recent years. These include an infrared light-based system from startup EarLens, which it cleared via the de novo premarket pathway for low- to moderate-risk medical devices that do not have an already marketed substantial equivalent device, as well as an approval for the first implantable hearing aid for startup Cochlear last year.
Notably, influential venture behemoth NEA has invested in at least a trio of hearing device startups. Most recently, it backed a $25 million Series B for Eargo with its relatively inexpensive, in-ear hearing device. In addition, it's also an investor in EarLens and Sonic Innovations, which uses Speech Variable Processing technology in its hearing aids to better detect the sound of the human voice.
- here is the FDA announcement